As a Senior Bioassay Analyst you will be responsible for planning and performing multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
- The Senior Bioassay Analyst will lead training of staff on technical aspects of job as required.
- You will develop, revise and implement procedures that comply with appropriate regulatory requirements.
- Complete qualification of analytical equipment and related testing functions.
- Participate in Analytical Method Transfers
- Compliance with Standard Operating Procedures and Registered specifications.
- Ensure the laboratory is operated in a safe manner
- Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
- Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
- Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
- Participate in regulatory agency inspections as required.
- Plan and implement procedures and systems to maximise operating efficiency.
- Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
- Have 2-3 years of experience in a pharmaceutical/healthcare Laboratory.
- Experience in Bioassays, Immunoassays and Cell Culture is essential.
- Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
- Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
- Knowledge of applicable Regulatory requirements
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